Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

NCT00882219 | Completed Phase 3

• 1 other identifier: 330704
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

Conditions

Coronary Restenosis

Keywords

Drug eluting stent; Stents; Angioplasty; Chronic coronary occlusion; Stent thrombosis; Vascular disease; Myocardial ischemia; Coronary artery stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Outcome Measures

Primary Outcomes (1)

• Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®

  9 months

Secondary Outcomes (10)

• Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent

  9 months

• Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent

  9 months

• Evaluation by QCA of the in-stent binary restenosis rate

  9 months

• Evaluation of the in-segment binary restenosis rate

  9 months

• Evaluation by QCA of in-segment late loss

  9 months

Study Arms (1)

Xience V®

EXPERIMENTAL

Device: Xience V®

Interventions

Xience V® DEVICE

Placement of a Xience V® stent within a restenosed bare metal stent.

Xience V®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Patients affiliated to a social security or equivalent regimen
• Patients agreeing to participate in the study (Patient with signed informed consent )
• Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia).
• Patient acceptable candidate for CABG surgery
• Patient agreeing to undergo all protocol scheduled follow-up examinations.
• Patients who tolerate the association Aspirin (dosed 75 to 160 mg/day) and Clopidogrel at 75 mg/day for at least 6 months
• Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions.
• Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate
• Patient with a target lesion ≤ 22mm by visual estimate
• Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade \> 1
• Patient with multiple lesions, the other lesions have been treated with success

You may not qualify if:

• Patient in emergency
• Patient pregnant
• Patient nursing
• Patient unable to give informed consent personally.
• Patient with myocardial infarction within the previous 72 hours.
• Patient with unstable arrhythmia
• Patient with left ventricular ejection fraction (LVEF) lesser than 30%
• Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant
• Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure.
• Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies
• Patient receiving chronically anticoagulant therapy with an INR greater than 2.5
• Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents.
• Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy.
• Patient with platelet count \<100 000/ mm3 or \>700 000mm3 ; WBC counts \<3 000/mm3 or known or suspected liver disease
• Patient with severe renal insufficiency (creatinine clearance rate \< 30 ml/min), or under dialysis

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Hopital de Rangueil - Chu

Toulouse, 31403, France

Location

MeSH Terms

Conditions

Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Didier Carrie, MD

  HOPITAL DE RANGUEIL - CHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 16, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

FR (1)